Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B
Information source: Chulalongkorn University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis B
Intervention: PEG-IFN and entecavir (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Chulalongkorn University Official(s) and/or principal investigator(s): Pisit Tangkijvanich, M.D., Principal Investigator, Affiliation: Chulalongkorn University
Overall contact: Pisit Tangkijvanich, M.D., Phone: +662-256-4482, Email: pisittkvn@yahoo.com
Summary
The outcome of treatment of chronic hepatitis B is determined by viral and host interaction,
thus the combination therapy of immunomodulator (PEG-IFN) and potent antiviral drug
(entecavir) should improve the response rate. In addition, the simultaneous assessment of
viral and host genetic factors associated with SVR may help to identify predictors of
treatment outcomes, which will in turn significant reduce the cost/effect of therapy
Clinical Details
Official title: A Randomized Design Study to Compare the Efficacy of Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B: Role of Host and Viral Factors Associated With Treatment Response
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: To determine whether a combination of PEG-IFN and entecavir improves the rate of sustained response and HBsAg clearance in patients with HBeAg-negative chronic hepatitis B
Secondary outcome: To determine host factors and viral factors associated with response to PEG-IFN alone or PEG-IFN plus entecavir treatment
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Men and women 18 to 65 years of age
- Patients with HBeAg-negative chronic hepatitis B
- Positive for HBsAg for at least 6 months, negative for anti-HBs and HBeAg
- Serum HBV DNA levels ≥ 2,000 IU/mL at screening
- Increased alanine aminotransferase (ALT) levels [greater than the upper limit of
normal (ULN) and less than 10xULN}
- No signs or symptoms of advanced liver disease
- Patient has had a liver biopsy within 1 year of screening
Exclusion Criteria:
- Patient had previous treatment with IFN, peg-IFN, and/or entecavir
- Patient has evidence or history of chronic hepatitis not caused by HBV, including but
not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and
autoimmune hepatitis
- Patient has co-infection with hepatitis C virus and/or human immunodeficiency virus
- Patients with liver cancer
- Female patient is pregnant, lactating, expecting to conceive or donate eggs, or is of
childbearing potential throughout treatment.
- Patient has any other condition that is contraindicated for treatment with PEG-IFN or
entecavir
- Patient has any condition or pre-study laboratory abnormality, or history of any
illness, which in the opinion of the investigator, might confound the results of the
study or pose additional risk in administering the study drug
Locations and Contacts
Pisit Tangkijvanich, M.D., Phone: +662-256-4482, Email: pisittkvn@yahoo.com
Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand; Recruiting Pisit Tangkijvanich, M.D., Phone: +662-256-4482, Email: pisittkvn@yahoo.com Pisit Tangkijvanich, M.D., Principal Investigator
Additional Information
Starting date: March 2011
Last updated: June 26, 2011
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